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Speed of Injection and Pain During Routine Infant Vaccinations

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ClinicalTrials.gov Identifier: NCT02504398
Recruitment Status : Unknown
Verified July 2015 by Anna Taddio, University of Toronto.
Recruitment status was:  Recruiting
First Posted : July 21, 2015
Last Update Posted : July 23, 2015
Information provided by (Responsible Party):
Anna Taddio, University of Toronto

Brief Summary:
Vaccine injections are a significant source of pain for infants. Altering the injection speed when administering vaccines may be an effective intervention and is feasible (cost neutral). At present, there are no data regarding impact of injection speed on vaccine injection pain in infants. The aim of this study is to address this knowledge gap and to compare the impact of slow and fast vaccine injection speeds on pain during routine infant vaccinations.

Condition or disease Intervention/treatment Phase
Routine Infant Immunizations Pain Management Other: Fast injection speed by immunizer Other: Slow injection speed by immunizer Phase 3

Detailed Description:
To date, there has been no evidence-based guidance regarding the rate at which vaccines should be injected to minimize pain. This has led to a disparity in practice. Some vaccinators favour a slow rate of injection (around 8-10 sec/mL) while others prefer a more rapid rate of injection (around 2-4 sec/mL).The slow injection method leads to a longer needle dwelling time with the increased possibility of the needle moving around and causing pain by damaging muscle tissue. Rapid injection, on the other hand, may lead to a sudden distension of muscle tissue, which itself could be painful. Allowing the muscle sufficient time to distend in order to accommodate the vaccine might minimize pain. This study will address the identified knowledge gap by comparing pain in infants undergoing routine vaccinations with a fast vs. slow injection speed.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 120 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Randomized Controlled Trial of Injection Technique for Infant Vaccination
Study Start Date : July 2015
Estimated Primary Completion Date : August 2016
Estimated Study Completion Date : August 2016

Arm Intervention/treatment
Experimental: Fast injection
Vaccine injections will be given at a rate of approximately 2-4 ml/sec by the immunizer
Other: Fast injection speed by immunizer
Active Comparator: Slow injection
Vaccine injections will be given at a rate of approximately 10 ml/sec by the immunizer
Other: Slow injection speed by immunizer

Primary Outcome Measures :
  1. Infant Behavioural Pain Score [ Time Frame: up to 1 minute post-vaccinations ]
    Assessed using the Modified Behavioural Pain Scale (0-10) from videotapes of the procedure

Secondary Outcome Measures :
  1. Infant Parent-rated Pain Score [ Time Frame: up to 2 minutes ]
    Assessed using a Numerical Rating Scale (0-10) by parent in real time

  2. Infant Cry duration [ Time Frame: up to 2 minutes ]
    Assessed in 1 minute intervals for 2 minutes following vaccinations from videotapes

Information from the National Library of Medicine

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Ages Eligible for Study:   2 Months to 7 Months   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

Inclusion Criteria:

  • Healthy 2 and 4 month old infants receiving their primary vaccine injections, PediacelTM (0.5mL) and PrevnarTM (0.5mL) (in conjunction with and preceded by oral RotarixTM vaccine) and healthy 6 month old infants receiving their routine vaccine injection, PediacelTM (0.5mL)

Exclusion Criteria:

  • Infants with impaired neurological development; history of seizures; administration of sedatives or narcotics in the preceding 24 hours; parental inability to use study tools; parent vaccine refusal; prior participation in the trial; and refusal to be video recorded

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02504398

Contact: Anna Taddio, PhD 416-813-6235 anna.taddio@utoronto.ca
Contact: Moshe Ipp, MD 416-416-924-1661 mm.ipp@utoronto.ca

Canada, Ontario
Pediatric Consultants Recruiting
Toronto, Ontario, Canada
Contact: Moshe M Ipp, MD    416-924-1661    mm.ipp@utoronto.ca   
Contact: Anna Taddio, PhD    416-813-6235    anna.taddio@utoronto.ca   
Sponsors and Collaborators
University of Toronto
Principal Investigator: Anna Taddio, PhD University of Toronto

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Anna Taddio, Professor, University of Toronto
ClinicalTrials.gov Identifier: NCT02504398     History of Changes
Other Study ID Numbers: 31803
First Posted: July 21, 2015    Key Record Dates
Last Update Posted: July 23, 2015
Last Verified: July 2015

Additional relevant MeSH terms:
Central Nervous System Stimulants
Physiological Effects of Drugs
Autonomic Agents
Peripheral Nervous System Agents
Dopamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Adrenergic Agents
Adrenergic Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
Dopamine Uptake Inhibitors